Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

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ClinicalTrials.gov Identifier: NCT01720394

Recruitment Status : Unknown

Verified August 2014 by Medical University of Graz. Recruitment status was: Recruiting

The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.

primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3.

Device: Cervical Ripening Balloon, Cook Medical Inc.

Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.

time interval from primary treatment to delivery [ Time Frame: maximum of 72 hours ]

the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured

Secondary Outcome Measures :

progress of labor [ Time Frame: maximum of 72 hours ]

time from balloon-application to dilatation of the cervix (cervical opening > 3cm, or Bishop Score ≥ 9 ) in therapy arm 1 and from dinoprostone-vaginal-insert-application to dilatation of the cervix (cervical opening > 3cm, or Bishop Score ≥ 9 ) in therapy arm 2

vaginal delivery [ Time Frame: maximum of 72 hours ]

Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.

failed induction of labor [ Time Frame: maximum of 72 hours ]

Number of patients who received caesarean section after frustrating induction of labor. Frustrating induction is defined as application of the cervical-ripening-balloon + 2 times application of dinoprostone-vaginal-insert in therapy arm 1 and 3 times application of dinoprostone-vaginal-insert in therapy arm 2.

patient's satisfaction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days ]

Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery

maternal parameters [ Time Frame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days ]

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